(41 days)
The Biosense Webster PENTARAY™ NAV eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The PENTARAY™ NAV eco High-Density Mapping Catheter provides location information when used with compatible CARTO™ 3 EP Navigation Systems. (This catheter is not compatible with CARTO™ 3 EP Navigation Systems prior to Version 3.x).
The Biosense Webster PENTARAY® Nav eco Mapping Catheter is a multi-electrode diagnostic catheter designed to facilitate electrophysiological mapping of all structures in the heart (recording and stimulation). The catheter's distal end is a flower-shaped probe with 5 spines that radiate from the center. Each spine has 4 ring electrodes that are used for stimulation and recording within the heart. The flower is available in a 30mm diameter and several ring spacing configurations to achieve optimal mapping and contact with various cardiac structures.
This document is a 510(k) summary for a medical device ([K201750](https://510k.innolitics.com/search/K201750): Pentaray Nav eco High-Density Mapping Catheter), which is submitted to the FDA for market clearance. It asserts that the device is substantially equivalent to a predicate device ([K123837](https://510k.innolitics.com/search/K123837)).
Therefore, the information you've requested regarding acceptance criteria and performance studies that would prove the device meets acceptance criteria in the context of an AI/machine learning device is not present in this document. This typically involves performance metrics like sensitivity, specificity, AUC, etc., derived from studies comparing algorithm output to ground truth.
This 510(k) specifically states:
- "The subject catheter is identical in design to the current catheter."
- "The intended use of the predicate device as a diagnostic catheter designed to facilitate mapping of structures within the heart remains the same in the subject device."
- "The purpose of this 510(k) submission is to add clarification to the precautions. There are no other changes between the subject device and the predicate device approved per K123837."
- "The PENTARAY™ NAV eco High-Density Mapping Catheter underwent bench and animal testing. The catheter passed all intended criteria in accordance with appropriate test criteria and standards."
This is a design modification submission (adding clarification to precautions) for an already cleared device, not a new device with novel AI algorithms requiring extensive clinical performance validation for its AI components with human-in-the-loop studies. The "Performance Data" section solely refers to bench and animal testing, which are standard for physical medical devices to ensure safety and functionality, not AI algorithm performance.
Therefore, I cannot provide the requested information from this document in the context of an AI/ML device. The document does not describe the kind of performance studies (e.g., MRMC, standalone algorithm performance) or the robust ground truth establishment methods typically associated with AI/ML device validation.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).